Our client, a medical device company in Cork are currently looking to recruit a Senior Validation Engineer on an hourly contracting basis.
- The Validation Engineer is a member of the QA Validation team, playing a key role in the planning and execution of validation activities related to project.
- Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project, is critical to the start-up, license approval and the on-going sustaining operations of facilities.
- All validation activities are conducted in compliance with US and EU legislation; as well as company Standards and Guidelines to allow a facility to be qualified in accordance with the project requirements of quality, safety, schedule and budget.
- Conduct validation activities in compliance with US and EU regulations, GBSC procedures and EHS requirements.
- Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
- Develop validation documentation as required (e.g. specifications, plans, protocols, procedures).
- Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
- Execute qualification protocols as required.
- Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
- Prepare reports of executed protocols for review by QA.
- Initiate and implement change control activities in accordance with site procedures.
- Track and resolve exceptions during qualification activities.
- Prioritize qualification activities in line with the project schedule.
- Co-ordinate qualification activities with engineering, construction and commissioning activities.
- Co-ordinate qualification activities with contractors and vendors as required.
- Co-ordinate qualification document review and approval.
- Collate and organize qualification files for turnover to QADC.
- Attend identified training, required to fulfil the role of Validation Engineer.
- Assist in the development of training material for qualification activities. ?
- Participate in cross-functional teams as required.
- Deputises for the QA Validation Manager when designated as appropriate.
- Domestic and international travel may be required.
Other Skills, Experience and Education
- A degree qualification in science or engineering.
- The person will have a proven track record in the qualification of any of the following systems:
- Qualification of Cell Culture Technologies.
- Qualification of Purification - Chromatography and Ultrafiltration Technologies.
- Qualification of Production Support Equipment.
- Qualification of Clean Utilities.
- Qualification of HVAC (ISO classes 5 to 8).
- Qualification of Control Systems - Emerson DeltaV, Honeywell Building Management Systems and Siemans PLCs. Qualification experience in a project environment within the pharmaceutical or biopharmaceutical industries. Knowledge and Interpretation of FDA/EMEA requirements applicable to the pharmaceutical or biopharmaceutical industries. Ability to apply CGMP regulations and guidelines to all aspects of qualification activities.
Key Competencies Required
- Excellent interpersonal skills
- Ability to operate as part of a team is critical and also the ability to work alone as required
- Customer focus
- Excellent communication skills both written and verbal
- Attention to detail
- Good problem solving skills
- Results and performance driven
- Adaptable and flexible
For further information on this Senior Validation Engineer role in Cork please contact Anne on 0212066287 / firstname.lastname@example.org
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